坎地沙坦酯氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100685-201903对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)8供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.217758077123775557719977305773520.27
216.337834278510784260.16
单位质量响应值RSD%判断
4771.874802.570.46数据可信
供试品溶液-6041401批-pH6.8(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min116649-1664919.52419.2412.5619.5219.2412.56
217806-1780620.88020.88
316006-1600618.77018.77
415173-1517317.79317.79
519360-1936022.70322.70
613441-1344115.76215.76
10min139241-3924146.01746.075.8546.0546.105.86
240500-4050047.49347.53
338543-3854345.19845.23
439664-3966446.51346.54
542346-4234649.65849.70
635434-3543441.55241.58
15min151507-5150760.40060.903.4060.5161.013.40
252692-5269261.79061.90
351439-5143960.32160.43
453253-5325362.44862.56
553811-5381163.10263.22
648889-4888957.33057.43
20min159678-5967869.98270.291.8870.1970.501.89
260961-6096171.48771.70
359614-5961469.90770.11
460987-6098771.51771.73
560430-6043070.86471.09
657998-5799868.01268.20
30min168903-6890380.80080.450.9581.1380.780.95
269042-6904280.96381.30
368879-6887980.77281.10
469237-6923781.19281.52
567898-6789879.62279.97
667682-6768279.36879.67
45min175230-7523088.22087.830.7688.6888.290.76
275515-7551588.55489.02
374901-7490187.83488.29
475305-7530588.30888.77
574052-7405286.83887.31
674403-7440387.25087.69
60min178214-7821491.71991.311.0392.3391.911.03
278841-7884192.45493.07
377857-7785791.30091.90
478395-7839591.93192.54
576696-7669689.93990.56
677169-7716990.49391.08
极限180167-8016794.00993.710.6494.7794.470.64
280731-8073194.67095.44
379484-7948493.20893.96
480081-8008193.90894.67
579475-7947593.19893.97
679534-7953493.26794.00
坎地沙坦酯氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100685-201903对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)8供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.217825878645787917840178439785070.27
216.337824378099781710.14
单位质量响应值RSD%判断
4843.124786.960.83数据可信
供试品溶液-6041501批-pH6.8(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min120031-2003123.35521.658.7723.3521.658.77
218886-1888622.02022.02
317866-1786620.83020.83
420453-2045323.84723.85
518230-1823021.25521.25
615955-1595518.60218.60
10min143013-4301350.15047.624.7550.1947.664.75
241870-4187048.81748.85
341577-4157748.47548.51
441037-4103747.84647.89
540192-4019246.86146.90
637380-3738043.58243.61
15min155875-5587565.14662.303.4965.2762.423.49
254717-5471763.79663.91
354362-5436263.38263.50
452421-5242161.11961.24
552400-5240061.09461.21
650838-5083859.27359.38
20min162850-6285073.27871.442.2373.5171.662.24
262186-6218672.50472.73
362040-6204072.33472.55
460748-6074870.82771.05
560758-6075870.83971.05
659069-5906968.87069.07
30min170793-7079382.53981.461.7182.8981.801.72
270817-7081782.56782.91
369685-6968581.24781.59
470378-7037882.05582.39
569899-6989981.49781.83
667620-6762078.83979.16
45min176180-7618088.82088.680.8789.3189.150.88
276863-7686389.61690.10
375744-7574488.31188.79
476727-7672789.45789.93
575692-7569288.25188.72
675141-7514187.60888.06
60min178952-7895292.05292.060.8192.6992.680.81
279838-7983893.08593.72
378128-7812891.09191.72
479566-7956692.76793.39
578631-7863191.67792.29
678648-7864891.69792.29
极限180945-8094594.37594.190.8595.1794.960.85
281643-8164395.18995.98
379826-7982693.07193.85
481256-8125694.73895.52
580141-8014193.43894.21
680887-8088794.30895.06
坎地沙坦酯氨氯地平片项目信息
介质体积(ml)900取样体积(ml)1.5补液体积(ml)1.5
对照品批号100685-201903对照品来源中检院对照品使用方法直接使用
对照品含量(%)99.8对照品水分(%)0对照品稀释倍数2000
标示量(mg)8供试品稀释倍数1系数1
对照品溶液
序号称样量(mg)A1A2A3A4A5A平均RSD%
116.217805578030780687777077934779710.16
216.337868278846787640.15
单位质量响应值RSD%判断
4810.064823.270.20数据可信
供试品溶液-6041502批-pH6.8(内含0.1%Tween)
时间
(分钟)
样品A1A2A平均溶出量(%)平均(%)RSD%累计溶
出量(%)
平均(%)RSD%
5min115753-1575318.36016.697.7118.3616.697.72
213888-1388816.18616.19
315065-1506517.55817.56
413607-1360715.85915.86
512745-1274514.85414.85
614876-1487617.33817.34
10min137693-3769343.93140.576.7243.9640.606.71
233982-3398239.60639.63
335015-3501540.81040.84
435077-3507740.88240.91
530812-3081235.91135.94
636299-3629942.30642.33
15min150305-5030558.63055.355.0758.7355.445.07
246452-4645254.13954.23
347428-4742855.27755.37
448281-4828156.27156.37
543394-4339450.57550.66
649080-4908057.20257.30
20min157616-5761667.15164.103.9867.3564.293.99
254112-5411263.06763.25
354833-5483363.90764.10
455756-5575664.98365.17
551289-5128959.77759.95
656397-5639765.73065.92
30min166212-6621277.16974.832.9377.4875.122.94
263819-6381974.38074.67
363830-6383074.39374.69
465082-6508275.85276.15
560879-6087970.95471.22
665409-6540976.23376.54
45min173691-7369185.88684.031.8986.3384.451.91
271471-7147183.29983.71
371371-7137183.18283.60
472740-7274084.77885.20
570080-7008081.67782.06
673255-7325585.37885.81
60min176689-7668989.38088.471.1189.9789.041.13
275691-7569188.21788.77
375632-7563288.14888.71
476561-7656189.23189.80
574461-7446186.78387.31
676434-7643489.08389.66
极限178719-7871991.74691.910.7692.4892.620.77
278533-7853391.52992.23
378264-7826491.21691.92
479162-7916292.26292.98
578576-7857691.57992.25
679918-7991893.14393.87
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